Fantastic News: A Revolutionary New Breast Cancer Drug Is on the Way

By Markets Fool.com


Source: Komen Austin via Flickr.

Continue Reading Below

With the exception of skin cancer, breast cancer is the most commonly diagnosed type of cancer, making up one in every seven diagnoses in 2014 and nearly three in 10 cancer diagnoses for women. All told, that equates to more than 235,000 estimated breast cancer diagnoses last year. It's also the second-leading cause of death for women, trailing only lung and bronchus cancer according to the American Cancer Society.

Instilling awareness and educating the public about its various risk factors, such as family history, obesity, and smoking, has been one way regulators have fought back against this disease. Simply making people aware of the factors that can increase their chances of developing breast cancer could lead them to a healthier lifestyle.

Source: Flickr user Shardayyy.

A reduction in hormone therapy has been another important factor in reducing breast cancer occurrence rates. This, combined with regular mammograms, has been a critical component to lowering breast cancer death rates by about a third since 1990!

Continue Reading Below

Of course, there's still a tough battle to be fought for patients who do have breast cancer. Even though five-year survival rates have jumped to 90% from 75% over a three-decade period, more work is needed to push survival rates and patient quality of life even higher. The good news is that fight may have just gotten a little easier this past week.

A revolutionary new breast cancer drug is on the way
On Tuesday evening Pfizer announced that the Food and Drug Administration had approved Ibrance (formerly palbociclib) in combination with Novartis' Femara as a first-line treatment for postmenopausal women with estrogen-positive, HER2-negative metastatic breast cancer, the most common type of breast cancer.

Ibrance is truly a revolutionary drug because it operates via an entirely new pathway. The drug is designed to block the CDK4 and CDK6 enzymes which are critical to the cell division process of a tumor. Therefore, blocking this cell division could slow or halt tumor growth.

The approval comes more than two months ahead of its scheduled PDUFA decision date. Not to mention Ibrance's approval was also accelerated by the breakthrough therapy designation which allows for rolling submissions and approvals with ongoing phase 3 trials acting as confirmation of safety and efficacy following approval.

In Pfizer's case Ibrance was approved by the FDA based on its remarkable improvement in progression-free survival. In the PALOMA-1 study, the group receiving Ibrance and Femara demonstrated a PFS of 20.2 months, nearly double the 10.2 months from the Femara-only control group. Disease stabilization was a clear mark of efficacy in this instance, and it's likely going to result in improved patient quality of life. Additionally, the overall response rate for the Ibrance arm was considerably higher than the Femara monotherapy arm (55.4% versus 39.4%).


Source: Pfizer.

Although no mention was made in the press release regarding median overall survival, the PALOMA-1 final results observed a 4.2-month improvement to 37.5 months in the Ibrance intent-to-treat arm compared to Femara alone.

Good news all around
The approval of Ibrance is good news all around.

Investors in Pfizer have essentially been kicking rocks for the past 15 years with its share price flat over that time, not including dividend payments. While Pfizer did have an exceptionally strong decade in the 2000's, it's been struggling mightily with patent expirations during the first-half of this decade, losing exclusivity on cholesterol-fighting drug Lipitor, the best-selling drug of all-time, as well as Celebrex, Spiriva in select countries, and Detrol. Pfizer needs a spark, and Ibrance may just provide that.

Source: Amgen, via Flickr.

Some Wall Street analysts are projecting that Ibrance will be a $3 billion drug by 2020, while a few estimates are even higher. Either way, Pfizer very much needs a home run like Ibrance to help buoy its sales and profits and ensure its 86-drug pipeline remains one of the biggest in the business.

Amgen , which acquired Onyx Pharmaceuticals, also receives 8% of all royalties on Ibrance net sales since Onyx collaborated with Pfizer to develop kinase inhibitory assays for the CDK enzymes.

But, let's face it, the big winners here are ER-positive, HER2-negative breast cancer patients which likely have a new standard of care. Not to mention, it's been far too long since we've had a substantial improvement in a first-line breast cancer indication for ER+/HER2- breast cancer (more than 10 years to be exact). Improved quality of life and longer survival is truly what this is all about!

Far from finished
Yet, the battle against breast cancer is far from finished. Until this disease is cured biopharmaceutical companies will continue to look for new and unique ways to fight it.

Source: Roche.

Last year, for instance, Roche , which has arguably the deepest oncology pipeline in the world, announced stunning survival data for its CLEOPATRA trial involving HER2-negative drug Perjeta. When Perjeta was combined with Herceptin and a chemotherapy and administered to advanced-stage HER2-positive breast cancer patients, it resulted in a median overall survival of 56.5 months. This was nearly 16 months better than the control group.

Small-cap Galena Biopharma has also delivered exciting results for its still clinical-stage cancer vaccine NeuVax. NeuVax is designed to treat patients with low-to-moderate levels of HER2-expression in a post-treatment setting. In other words, NeuVax's job is to act as an adjuvant treatment and ensure that a patient's breast cancer doesn't return. In phase 2 studies just 5.6% of patients receiving NeuVax had their cancer recur over a 60-month period, compared to 25.9% of patients in the control group. Galena's lead drug should yield results from its late-stage study in late 2016 or early 2017.

All told, this week marks another step in the right direction to fighting cancer. The steps being taken by researchers may seem small at times, but as long as we continue to invest in new therapies and pathways the end result should be improved quality of life and extended survival and that's a good thing!

The article Fantastic News: A Revolutionary New Breast Cancer Drug Is on the Way originally appeared on Fool.com.

Sean Williamshas no material interest in any companies mentioned in this article. He would like to wish his cousin Fern a swift and full recovery from her courageous fight against breast cancer. You can follow him on CAPS under the screen nameTMFUltraLong, track every pick he makes under the screen nameTrackUltraLong, and check him out on Twitter, where he goes by the handle@TMFUltraLong.The Motley Fool has no position in any of the stocks mentioned. Try any of our Foolish newsletter servicesfree for 30 days. We Fools don't all hold the same opinions, but we all believe thatconsidering a diverse range of insightsmakes us better investors. The Motley Fool has adisclosure policy.